As part of the ongoing regulatory changes under the EU Biocidal Products Regulation (EU BPR), several active substances used in biocidal products must be phased out of the Northern Ireland (NI) market. The affected substances, including iodine, n-decanoic acid, and polyvinylpyrrolidone iodine, are slated to expire by 31 August 2025, impacting a range of biocidal products across NI.
Substances Facing Expiry
Several key active substances, along with their respective product types, are set to reach their expiration date under the EU BPR:
- Iodine (CAS 7553-56-2 EC 231-442-4) in product types 1, 4, and 22
- n-Decanoic acid (CAS 334-48-5 EC 206-376-4) in product types 18 and 19
- n-Octanoic acid (CAS 124-07-2 EC 204-677-5) in product type 18
- Polyvinylpyrrolidone iodine (CAS 25655-41-8 EC 607-771-8) in product types 4 and 22
After 31 August 2025, these active substances will no longer be authorised for use in biocidal products of the relevant types within NI. Furthermore, treated articles containing these substances will be prohibited from being placed on the NI market.
Impact on Businesses
Holders of EU BPR product authorisations or Control of Pesticides Regulations (COPR) approvals are urged to review their current authorisations. Regulatory authorities will soon contact affected parties to commence the process of cancelling or revoking existing approvals. There will be an opportunity for stakeholders to provide comments or additional information, which will be considered before finalising decisions.
Businesses concerned about disproportionate negative impacts due to the expiry of these active substances are encouraged to contact regulators as soon as possible.
Renewal Deadline Approaches for Bacillus thuringiensis
In addition to the substances expiring in 2025, a key deadline is fast approaching for the renewal of another active substance under EU BPR. Bacillus thuringiensis subsp. kurstaki, strain ABTS-351 (used in product type 18) faces an approval expiry on 27 August 2025. Renewal applications must be submitted to the European Chemicals Agency (ECHA) 550 days before the expiry date to maintain the approval for use in NI.
Renewal applications can be submitted by any interested party, including companies, consortia, or task forces. If no renewal application is made, the approval will expire, barring further use of the active substance in the relevant product types.
Stakeholders relying on Bacillus thuringiensis in their biocidal products are urged to consult the EU Article 95 List to identify the original supporters of the substance. Suppliers should also be contacted to ensure they are aware of the renewal requirements.
Future Considerations
With several active substances due to expire, businesses in NI must take immediate action to prepare for the potential market withdrawal of affected products. Stakeholders should also consider supporting renewal applications for key substances to ensure the continued availability of important biocidal products. Failure to act could lead to disruption in the availability of widely used products in the NI market.
